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NCT04759911 · ClinicalTrials.gov registry record · Phase 2
Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer
A Phase 2 study of Poorly Differentiated Thyroid Gland Carcinoma and Thyroid Gland Papillary Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT04759911: Active Phase 2 study of Poorly Differentiated Thyroid Gland Carcinoma and Thyroid Gland Papillary Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT04759911 is a Phase 2 study of Poorly Differentiated Thyroid Gland Carcinoma and Thyroid Gland Papillary Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants, roughly in line with the 28-participant average among 6 other Poorly Differentiated Thyroid Gland Carcinoma trials with a reported enrollment target. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04759911, a Phase 2 study of Poorly Differentiated Thyroid Gland Carcinoma and Thyroid Gland Papillary Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial studies the effect of selpercatinib given before surgery in treating patients with thyroid cancer whose tumors have RET alterations (changes in the genetic material \[deoxyribonucleic acid (DNA)\]). Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving selpercatinib before surgery may help shrink the tumors and help control the disease.
Primary Outcome
Defined as the percentage of number of complete response or partial response in total number of patients treated. With ORR by Response Evaluation Criteria in Solid Tumors (RECIST), will report the percentages of patients that fall into each of the four categories: complete response, partial response, stable disease or progressive disease according to RECIST 1.1.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- PROCEDURE Therapeutic Conventional Surgery
- DRUG Selpercatinib
Study Locations (3)
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Michigan
- University of Michigan Health Systems - Ann Arbor
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-02-26 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 2 |
What the registry record for NCT04759911 still lists
NCT04759911 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, roughly in line with the 28-participant average among 6 other Poorly Differentiated Thyroid Gland Carcinoma trials with a reported enrollment target.
The record links to 7 conditions, with Poorly Differentiated Thyroid Gland Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04759911 reports a single indexed study location in Maryland, Michigan, Texas.
Frequently Asked Questions
What is clinical trial NCT04759911 about?
NCT04759911 is a clinical study titled "Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer". This phase II trial studies the effect of selpercatinib given before surgery in treating patients with thyroid cancer whose tumors have RET alterations (changes in the genetic material \[deoxyribonucleic acid (DNA)\]). Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes ...
What is the current status of trial NCT04759911?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2021-02-26. Estimated completion is 2027-11-30.
What conditions does trial NCT04759911 study?
This clinical trial studies the following conditions: Poorly Differentiated Thyroid Gland Carcinoma, Thyroid Gland Papillary Carcinoma, Thyroid Gland Anaplastic Carcinoma, Recurrent Thyroid Gland Carcinoma, Thyroid Gland Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04759911?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Therapeutic Conventional Surgery (PROCEDURE), Selpercatinib (DRUG).
Who is sponsoring clinical trial NCT04759911?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04759911 being conducted?
This trial has 3 study locations across Maryland, Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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